AA-1 SYSTEM

Haploscope

NEUROVISION, INC.

The following data is part of a premarket notification filed by Neurovision, Inc. with the FDA for Aa-1 System.

Pre-market Notification Details

Device IDK012530
510k NumberK012530
Device Name:AA-1 SYSTEM
ClassificationHaploscope
Applicant NEUROVISION, INC. 12300 TWINBROOK PKWY. SUITE 230 Rockville,  MD  20852
ContactRichard E Lippman
CorrespondentRichard E Lippman
NEUROVISION, INC. 12300 TWINBROOK PKWY. SUITE 230 Rockville,  MD  20852
Product CodeHJT  
CFR Regulation Number886.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-06
Decision Date2001-08-31
Summary:summary

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